ModSpace sold for $1.1 billion

Williams Scotsman to acquire ModSpace for approx. $1.1B

ModSpace sold for $1.1 billion, Stockwinners
ModSpace sold for $1.1 billion, Stockwinners

WillScot Corporation (WSC) announced that it has entered into a definitive agreement to acquire Modular Space Holdings, the parent holding company of Modular Space Corporation, for an enterprise value of approximately $1.1B. Williams Scotsman will indirectly acquire MS Holdings for a purchase price comprising $1,063,750,000 of cash consideration, 6,458,500 shares of WSC Class A common stock and warrants to purchase 10,000,000 shares of WSC Class A common stock at an exercise price of $15.50 per share, subject to customary adjustments.

The transaction, which is subject to customary closing conditions, is expected to close in 3Q18.

ModSpace, a privately-owned provider of office trailers, portable storage units and modular buildings, had approximately $1.1B of total assets as of March 31, 2018.

ModSpace generated $453M of total revenue, $18M of net income and $106M of Adjusted EBITDA for the twelve months ended March 31, 2018. Once combined, Williams Scotsman will have over 160,000 modular space and portable storage units serving a diverse customer base from approximately 120 locations across the United States, Canada and Mexico.

Williams Scotsman expects to capture $60M in annual cost synergies after integration, with approximately 80% of the forecast synergies expected to be realized on a full run-rate basis by the end of 2019.

Williams Scotsman also expects to benefit from the net operating tax loss carryforwards to be acquired in the transaction, and for the transaction to be accretive to earnings in 2019.

Williams Scotsman expects to expand its “Ready to Work” value proposition across the ModSpace fleet and customer base, a strategy that has driven double-digit organic Adjusted EBITDA growth in Williams Scotsman’s U.S. Modular segment in recent years and proven successful in Williams Scotsman’s acquisitions of Acton Mobile and Tyson Onsite.

Until the transaction closes, both companies will operate independently and execute on their respective strategic priorities. Williams Scotsman has secured committed financing to fund the transaction, which includes an amendment and expansion of its existing revolving ABL credit facility to $1.35B with an accordion feature allowing up to $1.8B of total capacity, a $280M secured bridge credit facility, and $320M unsecured bridge credit facility.

Williams Scotsman expects the permanent financing plan to include a combination of long-term debt and equity or equity-linked securities.

WSC closed at $12.15, it last traded at $14.10.


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Supreme Court ruling moves retail stocks

Physical retailers rise, online retailers drop after Supreme Court tax ruling

Supreme Court ruling moves retail stocks, Stockwinners
Supreme Court ruling moves retail stocks, Stockwinners

Shares of brick-and-mortar retailers are rising, while shares of e-commerce firms are slipping, after the Supreme Court ruled that online retailers can be required to collect sales taxes in states where they have no physical presence.

SUPREME COURT RULING

On Thursday, the Supreme Court sided with the state of South Dakota in a fight it brought against Wayfair (W) to require a business that has no physical presence in the state to collect its sales tax.

Supreme Court ruling moves retail stocks, Stockwinners
Supreme Court ruling moves retail stocks, Stockwinners

The Supreme Court ruled in a 5-to-4 vote that a 1992 judgement in Quill Corporation v. North Dakota regarding the physical presence rule was “unsound and incorrect,” according to a judgement posted to the high court’s website.

Justice Anthony Kennedy, in writing for the majority opinion, said the Quill decision had distorted the economy and resulted in states losing annual tax revenues between $8B-$33B.

“Quill puts both local businesses and many interstate businesses with physical presence at a competitive disadvantage relative to remote sellers,” he wrote.

“Remote sellers can avoid the regulatory burdens of tax collection and can offer de facto lower prices caused by the widespread failure of consumers to pay the tax on their own.”

WHAT’S NOTABLE:

Following the ruling, industry trade organization National Retail Federation issued a statement saying,

“Retailers have been waiting for this day for more than two decades. The retail industry is changing, and the Supreme Court has acted correctly in recognizing that it’s time for outdated sales tax policies to change as well.

This ruling clears the way for a fair and level playing field where all retailers compete under the same sales tax rules whether they sell merchandise online, in-store or both.”

ANALYST COMMENTARY

KeyBanc analyst Edward Yruma called the ruling a negative for Wayfair, arguing that it may reduce some of the price differential that has helped it gain share from traditional peers.

The ruling is also a negative, but to a lesser degree, for eBay (EBAY) and Etsy (ETSY), said Yruma, who views the impact on those two as more related to compliance and implementation.

He adds that the news could be a modest positive for retailers of high-ticket and branded products, such as Best Buy (BBY), Home Depot (HD), Lowe’s (LOW), La-Z-Boy (LZB), Kirkland’s (KIRK), RH (RH) and Williams-Sonoma (WSM).

PRICE ACTION

At Thursday midday, Target (TGT) rose 1.8%, Walmart (WMT) was up 0.7%, Costco (COST) rose roughly 1.1% while Amazon (AMZN) was down 0.4%, Etsy dropped about 2.5%, eBay fell 1.4% and Wayfair (W) was down 1.2%.

In addition, Avalara (AVLR), a software company focused on automated tax compliance that recently held its initial public offering, gained 17.1%.


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Incyte says REACH1 trial met primary endpoint

Incyte says REACH1 trial met primary endpoint of ORR for Ruxolitinib

Incyte says REACH1 trial met primary endpoint, Stockwinners
Incyte says REACH1 trial met primary endpoint, Stockwinners

Incyte (INCY) announced positive topline results from its ongoing pivotal Phase 2 REACH1 trial evaluating ruxolitinib, or Jakafi, in combination with corticosteroids for the treatment of patients with steroid-refractory acute graft-versus-host disease.

The study met its primary endpoint, demonstrating an overall response rate of 55% at Day 28.

In addition, the best overall response rate , the number of patients achieving a response at any time point during the study, was 73%.

The most common treatment-emergent adverse events of any grade were anemia, thrombocytopenia and neutropenia.

Based on these data from REACH1, Incyte plans to file a Supplemental New Drug Application for the approval of ruxolitinib for the treatment of steroid-refractory acute GVHD with the U.S. FDA during the third quarter of 2018.

“The results of the REACH1 study demonstrate the potential of ruxolitinib to meaningfully improve the outcomes of allogeneic transplant patients who develop steroid-refractory acute GVHD and further underscore the promise of JAK inhibition to advance the treatment of this potentially-devastating condition,” said Steven Stein, M.D., Chief Medical Officer, Incyte.

“We look forward to sharing additional results from this study with the medical community, and to working with U.S. regulatory authorities to submit our supplementary new drug application seeking approval of ruxolitinib in this indication later this year.”

INCY closed at $73.43, it last traded at $74.65.


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Tesaro could be sold shortly

Analysts weigh in on Tesaro buyout value amid report of Roche interest 

 

Tesaro could be sold soon, Stockwinners
Tesaro could be sold soon, Stockwinners

According to a report by Intereconomia, Roche (RHHBY) is working with Citibank on a potential acquisition of Tesaro (TSRO).

While both companies are not commenting on the article, Citi analyst Robyn Karnauskas said Tesaro could be valued at $140-$213 per share in an M&A situation, while her peer at Suntrust sees a potential buyout value range of $109-$196.

INTERECONOMIA REPORT

Spanish media group Intereconomia reported that Roche, following its acquisition of Foundation Medicine (FMI) (see our blog here), is working with Citibank on a potential deal to buy Tesaro.

Earlier this month Tesaro entered into a clinical collaboration with Roche unit Genentech to evaluate the combination of the PD-L1 antibody atezolizumab.

Intereconomia, citing sources close to the situation, added that Roche could announce the acquisition of Tesaro in the coming days.

Tesaro said it does not “comment on market rumors,” while Roche gave a similar answer to Bloomberg.

TESARO TAKEOUT VALUE

In a research note to investors this morning, Citi’s Karnauskas said that her M&A analysis for Tesaro suggests the company could be valued at $140-$213 per share in a takeover scenario.

Karnauskas noted, however, that she does not assign any value to Zeluja expansion opportunities in platinum resistant ovarian cancer and metastatic castration resistant prostate cancer.

The analyst reiterated a Buy rating and $100 price target on Tesaro shares.

Meanwhile, SunTrust analyst Peter Lawson told investors that his takeover analysis suggests a potential buyout value of $153 per share for Tesaro, with a range of $109-$196.

The analyst argued that Intereconomia’s report could also be a potential positive for the biotechnology space, mainly Clovis Oncology (CLVS) and oncology peers.

Lawson reiterated a Buy rating and $150 price target on Tesaro’s shares.

PRICE ACTION

In Wednesday afternoon trading, shares of Tesaro have gained almost 15% to $45.92, while Roche’s stock has advanced over 2% to $27.11 and Clovis shares are up 5% to $48.10.


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Cotiviti sold for $4.9 billion

Cotiviti to be acquired by Veritas Capital-backed Verscend for $4.9B in cash

Cotiviti sold for $4.9 billion, Stockwinners
Cotiviti sold for $4.9 billion
Cotiviti Holdings (COTV) and Verscend Technologies, a portfolio company of Veritas Capital announced that they have entered into a definitive agreement whereby Verscend has agreed to acquire Cotiviti for $4.9B in cash.
Under the terms of the agreement, Cotiviti shareholders will receive $44.75 in cash per share of Cotiviti common stock, and Verscend will assume all of Cotiviti’s outstanding debt, resulting in an enterprise value of approximately $4.9B.
The offer price represents a 32% premium to Cotiviti’s unaffected share price as of June 4, 2018 and a 136% premium to the initial public offering price of Cotiviti’s common stock.
The transaction, which was unanimously approved by Cotiviti’s Board of Directors, is expected to close during the fourth quarter of 2018.
Closing of the transaction is subject to the approval of Cotiviti shareholders and the satisfaction of customary closing conditions, including applicable regulatory approvals.
Advent International has entered into a voting agreement whereby it has agreed to vote shares representing approximately 44% of the company’s voting power in favor of the transaction.


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Foundation Medicine sold for $2.4 billion

Roche acquires Foundation Medicine for $137 per share or $2.4B

Foundation Medicine sold or $2.4B, Stockwinners
Foundation Medicine sold or $2.4B

Roche (RHHBY) and Foundation Medicine (FMI) announced they have entered into a definitive merger agreement for Roche to acquire the outstanding shares of Foundation Medicine not already owned by Roche and its affiliates at a price of $137.00 per share in cash.

This corresponds to a total transaction value of $2.4B on a fully diluted basis, and a total company value of $5.3B on a fully diluted basis. This price represents a premium of 29% to FMI’s closing price on June 18.

The merger agreement has been unanimously approved by the board of Roche and a Special Committee of the independent directors of FMI and by its full board of directors with the Roche designated directors abstaining from the deliberations and vote.

All current members of the FMI board have indicated that they intend to tender their FMI shares in the tender offer. Under the terms of the merger agreement, Roche will promptly commence a tender offer to acquire all of the outstanding shares of FMI’s common stock not already owned.

The closing of the tender offer will be subject to a majority of FMI’s outstanding shares not already held by Roche being tendered in the tender offer, it noted.

In addition, the transaction is subject to other customary closing conditions. Following completion of the tender offer, Roche will acquire all remaining shares at the same price of $137 per share through a second step merger.

The closing of the transaction is expected to take place in the second half of 2018. Daniel O’Day, CEO Roche Pharmaceuticals, said, “This is important to our personalised healthcare strategy as we believe molecular insights and the broad availability of high quality comprehensive genomic profiling are key enablers for the development of, and access to, new cancer treatments.

We will preserve FMI’s autonomy while supporting them in accelerating their progress.”

FMI closed at $106.45. RHHBY closed at $26.39.


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Rent-A-Center sold for $1.365 billion

Rent-A-Center to be acquired by Vintage Capital for $15 per share in cash

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Rent-A-Center sold for $1.365 billion

Rent-A-Center (RCII) announced that it has entered into a definitive agreement with Vintage Rodeo Parent, LLC, an affiliate of Vintage Capital Management, LLC, pursuant to which Vintage will acquire all of the outstanding shares of Rent-A-Center common stock for $15.00 per share in cash.

The transaction, which is not subject to a financing condition, and is expected to close by the end of 2018, subject to customary closing conditions including the receipt of stockholder and regulatory approvals, represents a total consideration of approximately $1.365B, including net debt.

Under the terms of the Merger Agreement, Rent-A-Center stockholders will receive $15.00 in cash for each share of Rent-A-Center common stock, which represents a premium of approximately 49 percent over the Company’s closing stock price on October 30, 2017, immediately prior to the announcement that the Company’s Board of Directors initiated a process to evaluate strategic and financial alternatives focused on maximizing stockholder value.

The Rent-A-Center Board has unanimously approved the transaction and recommends that stockholders vote in favor of the transaction.

Upon completion of the transaction, Rent-A-Center will become a privately held company and its common shares will no longer be listed on any public market.

“The Rent-A-Center Board, having just completed a comprehensive review of strategic and financial alternatives in consultation with outside legal and financial advisors, unanimously supports this transaction and is confident it maximizes value for stockholders while delivering a significant and immediate cash premium,” said Mitch Fadel, CEO of Rent-A-Center.

RCII closed at $12.03.


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ImmunoGen higher on FDA decision

ImmunoGen announces FDA fast track designation for mirvetuximab soravtansine

ImmunoGen announces FDA fast track designation for mirvetuximab soravtansine , Stockwinners
ImmunoGen announces FDA fast track designation for mirvetuximab soravtansine

ImmunoGen (IMGN) announced that the U.S. FDA has granted Fast Track designation for its lead program, mirvetuximab soravtansine.

The designation is for the treatment of patients with medium to high folate receptor alpha-positive platinum-resistant ovarian cancer who received at least one, but no more than three prior systemic treatment regimens, and for whom single-agent chemotherapy is appropriate as the next line of therapy.

Mirvetuximab soravtansine is being evaluated in the FORWARD I Phase 3 trial.

The trial is designed to randomize 333 patients 2:1 to receive either mirvetuximab soravtansine or the physician’s choice of single-agent chemotherapy.

Eligibility criteria include patients with platinum-resistant ovarian cancer that express medium or high levels of FRalpha who have been treated with up to three prior regimens.

The primary endpoint of this study is Progression Free Survival, which is being assessed in the entire study population and in the subset of patients with high FRalpha expression.

Enrollment of FORWARD I was completed ahead of schedule in April 2018 and ImmunoGen expects to report top-line results from the FORWARD I trial in the first half of 2019. ImmunoGen is partnering with the Gynecologic Oncology Group Foundation Inc., a leader in clinical research in gynecologic malignancies, on FORWARD I, which is being conducted in North America and Europe.

This trial is intended to support full marketing approval of mirvetuximab for patients with platinum-resistant ovarian cancer.

Mirvetuximab soravtansine is also being assessed in multiple combinations in the FORWARD II trial.

FORWARD II is a Phase 1b/2 study of mirvetuximab in combination with Avastin, or Keytruda in patients with FRalpha-positive platinum-resistant ovarian cancer, primary peritoneal, or fallopian tube tumors, as well as a triplet combination of mirvetuximab plus carboplatin and Avastin in patients with platinum-sensitive ovarian cancer.

IMGN closed at $10.01, it last traded at $10.65.


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Bluebird Bio reports data from Phase 1 HGB-206

Bluebird Bio reports interim data from Phase 1 HGB-206 study of LentiGlobin

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Bluebird Bio reports interim data from Phase 1 HGB-206 study of LentiGlobin

bluebird bio (BLUE) announced new interim data from the ongoing HGB-206 Phase 1 multicenter clinical study of LentiGlobin investigational gene therapy in patients with severe sickle cell disease will be presented in an oral presentation on Saturday, June 16 at the 23rd Congress of the European Hematology Association by Julie Kanter, M.D., Medical University of South Carolina, Charleston, South Carolina.

“The consistent production of increased amounts of anti-sickling HbAT87Q in the Group C patients reflects the substantial positive impact of the changes introduced with the amended HGB-206 study protocol and refined manufacturing process.

All four Group C patients with greater than or equal to three months follow-up are making over 30 percent anti-sickling HbAT87Q.

The first patient treated, now with six months of follow-up, is producing over 60 percent anti-sickling HbAT87Q with a normal total hemoglobin level of 14.2 g/dL,” said David Davidson, M.D., chief medical officer, bluebird bio.

“The upward trajectory in Group C at these early time points suggests the potential for these patients to exceed the initially proposed therapeutic target of 30 percent anti-sickling HbAT87Q. We continue to define the development plan with regulatory authorities, and with further follow-up, we hope to see even higher levels of HbAT87Q, as well as sustained clinical benefit for patients.”

“The early data from Group C patients are very exciting and provide increasing confidence that LentiGlobin has the potential to deliver transformative benefit to patients. The longer-term data from patients treated earlier in the study show that levels of anti-sickling HbAT87Q in patients with SCD treated with LentiGlobin remain stable for at least two years,” said Dr. Kanter, a lead investigator of the HGB-206 study.

“Treatment options that can address the underlying cause of sickle cell disease are limited and LentiGlobin gene therapy has the potential to prevent or substantially reduce damaging symptoms associated with this debilitating disease.”

Separately, bluebird bio announced that new data from the completed Phase 1/2 Northstar (HGB-204) study in adolescents and adults with transfusion-dependent beta-thalassemia and any genotype, and its ongoing, Phase 3 Northstar-2 (HGB-207) multicenter clinical study of LentiGlobin investigational gene therapy in patients with TDT and non-beta0/beta0 genotypes, will be presented in an oral session on June 16 at the 23rd Annual Congress of the European Hematology Association by Franco Locatelli, M.D., Ph.D., of the IRCCS Ospedale Pediatrico Bambino Gesu of Rome, Italy.

“The maturing data from HGB-204 and HGB-207 suggest that one-time treatment with LentiGlobin may address the underlying genetic cause of TDT.

With our refined manufacturing process, the majority of patients with TDT and non-beta0/beta0 genotypes are transfusion-free and producing total hemoglobin at normal or near-normal levels,” said David Davidson, M.D., chief medical officer, bluebird bio.

“We are on track to submit a marketing authorization application in the European Union later this year, and we continue to work closely with clinical investigators and regulatory authorities to complete our ongoing clinical trials and bring this important treatment option to patients as soon as possible.”

“Consistently higher in vivo vector copy numbers and HbAT87Q hemoglobin levels in patients indicate that LentiGlobin manufacturing refinements have resulted in improved gene therapy characteristics and may enable sustained transfusion independence for a great majority of patients,” said Professor Locatelli, the lead investigator of the Northstar-2 study.

“Further, we are now seeing more than three years of data from the Northstar study indicating that LentiGlobin therapy may enable long-term transfusion independence in the majority of patients with non-beta0/beta0 genotypes.

These results hold the promise to change the natural history of many patients with this severe genetic disorder of hemoglobin production.”

BLUE closed at $197.00. It last traded at $204.65.


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Oracle lower after losing business to Amazon, Microsoft

Oracle slides as JPMorgan cuts rating on business lost to Amazon, Microsoft

Oracle slides as JPMorgan cuts rating on business lost to Amazon, Microsoft , Stockwinners
Oracle slides as JPMorgan cuts rating on business lost to Amazon, Microsoft ,

Shares of Oracle (ORCL) are sliding after JPMorgan analyst Mark Murphy downgraded the stock to Neutral, citing negative results from a survey of Chief Information Officers about their spending.

The analyst noted that the survey showed spending contraction ahead as Oracle’s databases are being unplugged in favor of Microsoft (MSFT) and Amazon (AMZN) databases.

SURVEY SAYS

In a research note this morning, JPMorgan’s Murphy downgraded Oracle to Neutral from Overweight as specific metrics in the firm’s large-scale CIO survey have arced over into negative territory.

The analyst told investors that while Oracle’s shares have risen from the $30s into the high $40s in the last 2 years, the company’s fundamental performance has remained inconsistent. Citing his survey of 154 CIOs, Murphy noted that Oracle received the largest number of indications for planned spending contraction this year, materially more than the second-worst company, which was IBM (IBM) with 25 indications of spending contraction.

Further, while ranking the top 8 or 9 mega-vendors in terms of who will be most critical and indispensable to CIOs’ IT environment in the future, Oracle only received 6.5% of votes, down from 11% in previous surveys, the analyst highlighted.

At the same time, Murphy pointed out that Amazon AWS improved from 9.5% of votes last year to 14.9% of votes this year, creating the appearance of a “sucking sound” out of Oracle and into AWS.

The company also ranked number 8 in terms of association with Digital Transformation projects, disappointing relative to its scale and lagging behind the likes of SAP (SAP), IBM, and Cisco (CSCO), he added, noting that despite Oracle’s efforts to build a Cloud presence, it rated no better than SAP in terms of association with Cloud Computing plans, and is nowhere close to the leaders Microsoft, Amazon, and Google (GOOGL; GOOG) in this respect. Oracle was mentioned by only 2% of the CIOs as the platform that will be “most integral” to their cloud computing plans, Murphy said.

Overall, the analyst questions where Oracle’s business and stock are heading in the next couple of years if the largest-scale CIO survey shows Oracle now has negative spending intentions, is lagging in Digital Transformation projects, is trailing in Cloud Computing plans, its databases are being unplugged in favor of Microsoft and Amazon databases, its applications are being unplugged in favor of Salesforce (CRM) and Workday (WDAY) applications, and customers are weary of its unpopular commercial tactics.

Murphy also lowered his price target on Oracle’s shares to $53 from $55.

WHAT’S NOTABLE

In a research note of his own, Nomura Instinet analyst Christopher Eberle lowered his price target for Oracle to $60 from $64 ahead of the company’s fourth quarter results on June 19.

The analyst trimmed his estimates to account for currency and expectations for more modest revenue acceleration in fiscal 2019. He remains optimistic, however, on Oracle’s transition and model growth reacceleration as the year progresses. Eberle reiterated a Buy rating on the shares.

PRICE ACTION

In Wednesday’s trading, shares of Oracle dropped almost 5% to $46.14.


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Alexion Pharmaceuticals presents results from ALXN1210

Alexion to present results from ALXN1210 Phase 3 study at EHA

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Alexion to present results from ALXN1210 Phase 3 study at EHA

Alexion Pharmaceuticals (ALXN) announced that results from one of the two large Phase 3 studies of ALXN1210, the company’s investigational long-acting C5 complement inhibitor, in patients with paroxysmal nocturnal hemoglobinuria were selected for presentation during the Late-Breaking Oral Session on Sunday, June 17, 2018 at the Annual Conference of the European Hematology Association in Stockholm, Sweden.

“We are very excited about EHA’s recognition of the robustness and importance of these data in complement inhibitor treatment-naive patients. We enrolled a very broad patient population, representative of patients with PNH in clinical practice, including patients with a history of aplastic anemia, and ‘classic’ PNH, as well as transfused and non-transfused patients,” said John Orloff, M.D., EVP and Head of Research & Development at Alexion.

“We look forward to discussing the data with leading hematologists in Europe at the conference later this week as part of our ambition to make ALXN1210 the new standard of care for patients with PNH.”

As previously announced, weight-optimized treatment every eight weeks with ALXN1210 demonstrated non-inferiority to treatment every two weeks with Soliris in complement inhibitor treatment-naive patients with PNH on the two co-primary endpoints and all four key secondary endpoints.

The numeric results for all these endpoints, including breakthrough hemolysis, favored ALXN1210 and are consistent with the immediate and complete C5 inhibition observed by the end of the first infusion of ALXN1210 and sustained throughout the entire 26-week treatment period.

The safety profile of ALXN1210, based on almost 180 patient years of experience, was similar to that of Soliris.

Paroxysmal nocturnal hemoglobinuria (PNH) is a chronic, progressive, debilitating, and potentially life-threatening ultra-rare blood disorder that can strike men and women of all races, backgrounds, and ages without warning, with an average age of onset in the early 30s.

PNH often goes unrecognized, with delays in diagnosis ranging from one to more than 10 years. In patients with PNH, chronic, uncontrolled activation of the complement system, a component of the body’s immune system, results in hemolysis (the destruction of red blood cells), which in turn can result in progressive anemia, fatigue, dark urine, and shortness of breath.

The most devastating consequence of chronic hemolysis is thrombosis (the formation of blood clots), which can damage vital organs and cause premature death.

Historically, it had been estimated that one in three patients with PNH did not survive more than five years from the time of diagnosis.

PNH is more common among patients with disorders of the bone marrow, including aplastic anemia (AA) and myelodysplastic syndromes (MDS).9,10,11 In certain patients with thrombosis of unknown origin, PNH may be an underlying cause.

ALXN closed at $118.20.


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Galmed reports positive results, shares jump

Galmed reports 52-week results from Phase 2b ARREST study

Galmed reports positive results, shares jump, Stockwinners
Galmed reports positive results, shares jump, Stockwinners

Galmed (GLMD) announced top-line, 52-week results from the global Phase 2b ARREST study. In the ARREST study, patients underwent MRS and biopsy at baseline and week 52, which were centrally read, blinded to treatment allocation.

The primary endpoint of the study was the change from baseline to end of study in liver triglycerides ratio as measured by MRS (Aramchol 600mg vs. placebo).

Secondary endpoints, demonstrated through biopsy, included fibrosis improvement by at least one stage or more without worsening of NASH (defined by an increase of inflammation and or ballooning) and NASH resolution (defined by ballooning score 0 and inflammation score 0-1 at termination) without worsening of fibrosis.

Other secondary endpoints included improvement (2 points or more) in NASH activity index, as measured by NAS or SAF, without worsening fibrosis and change in baseline to week 52/termination in ALT. 247 patients with biopsy-proven NASH who were overweight or obese and had pre-diabetes or type II diabetes mellitus were randomized in a ratio of 2:2:1 (600 mg, 400 mg and placebo).

Baseline histology of enrolled patients demonstrated a population with advanced disease, with 60% having stage 2 and 3 fibrosis and 70% having NAS greater than or equal to 5 at baseline.

Results from the study showed a statistically significant reduction in liver fat by MRS with Aramchol 400mg vs. placebo and not with 600mg.

Further, analysis of MRS responders defined by a reduction of greater than or equal to 5% absolute change from baseline demonstrated a clinically and statistically significant effect of Aramchol 600 mg vs placebo.

Results for the two biopsy endpoints, which may currently constitute a primary endpoint for a Phase 3 trial to support an FDA marketing application, demonstrated the following: (i) significantly more patients treated with Aramchol 600mg vs. placebo achieved NASH resolution without worsening of fibrosis (16.7% vs. 5.0%; p=0.0514) and NASH resolution; and (ii) a higher proportion of patients showed at least one-point improvement in fibrosis score without worsening of NASH in Aramchol 600 mg vs. placebo.

Statistically significant reductions in live enzymes alanine transaminase and aspartate transaminase were demonstrated in both Aramchol arms vs. placebo, respectively. Secondary endpoints based on NAS and SAF activity score, greater than or equal to 2 points improvement, show a higher proportion of patients with improvement in the Aramchol arms.

At 52 weeks of treatment, Aramchol continues to show a favorable safety and tolerability profile. Serious Adverse Events were reported in 12.5%, 8.9% and 9.2% of patients in placebo, Aramchol 400mg and 600mg arms, respectively.

No clustering of event type or atypical events for the studied population were reported in either Aramchol arms.

Early terminations due to adverse events occurred in 4.2%, 3.0% and 4.1% in placebo, Aramchol 400 mg and 600 mg arms, respectively.

GLMD closed at $7.05, it last traded at $18.65.


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Envision Healthcare sold for $9.9B

Envision Healthcare to be acquired by KKR for approximately $9.9B

 

Envision Healthcare sold for $9.9B, Stockwinners
Envision Healthcare sold for $9.9B, Stockwinners

Envision Healthcare (EVHC) announced it has entered into a definitive agreement to be acquired by global investment firm KKR (KKR) in an all-cash transaction for approximately $9.9B, including the assumption or repayment of debt.

Under the terms of the agreement, which has been unanimously approved by Envision’s Board of Directors, KKR will acquire all of the outstanding shares of Envision’s common stock for $46.00 per share in cash, representing a 32% premium to Envision’s volume-weighted average share price from November 1, 2017, the day immediately following the company’s first announcement that it was reviewing strategic alternatives.

The transaction price represents a multiple of 10.9x trailing 12 months Adjusted EBITDA and 10.1x 2018 anticipated Adjusted EBITDA.

The agreement represents the culmination of the Board’s comprehensive review of strategic alternatives to enhance shareholder value.

During the last seven months, the Board, with the assistance of three independent financial advisors and legal counsel, examined a full range of options to generate shareholder value, including capital structure alternatives, potential acquisitions, portfolio optimization, a potential sale of the whole company, and continued operation as a standalone business.

The Board oversaw an extensive process that involved outreach to 25 potential buyers, including financial sponsors and strategic entities, and invited proposals for all or parts of the business.

After consideration of the opportunities, risks and uncertainties facing the company and the broader sector, as well as the alternatives available to the company, the Board determined that the KKR proposal presented the best opportunity to maximize value for shareholders.

The completion of the transaction, which is targeted for the fourth quarter of 2018, is subject to customary closing conditions and regulatory approvals. Envision intends to present the proposed transaction to its shareholders for approval at the company’s 2018 Annual Meeting, which will be scheduled as soon as practicable following the filing and review of proxy materials.

The company intends to hold its Annual Meeting no later than October 1, 2018.

Upon the completion of the transaction, Envision will become a private company, and its common stock will no longer be traded on the New York Stock Exchange. KKR will be making the investment primarily from its KKR Americas Fund XII.


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A.V. Homes sold for $963 million

Taylor Morrison to acquire A.V. Homes for $21.50 per share

A.V. Homes sold for $963 million, Stockwinners
A.V. Homes sold for $963 million

Taylor Morrison Home (TMHC) and AV Homes (AVHI) announced that they have entered into a definitive agreement pursuant to which Taylor Morrison will acquire all of the outstanding shares of AV Homes common stock at $21.50 per share in a cash and stock transaction valued, including outstanding AV Homes debt, at approximately $963M.

The transaction has been unanimously approved by the boards of both Taylor Morrison and AV Homes and will be submitted to the stockholders of AV Homes for approval.

The transaction is expected to close late in Q3 or early in Q4 and the closing is subject to customary closing conditions. TPG Capital, the holder of approximately 40% of AV Homes common stock, has agreed to vote all of its shares of AV Homes common stock in favor of the transaction.

Under the terms of the agreement, AV Homes stockholders will have the option to receive, at their election, consideration per share equal to $21.50 in cash, 0.9793 shares of Taylor Morrison Class A common stock or the combination of $12.64 in cash and 0.4034 shares of Taylor Morrison Class A common stock, subject to an overall proration of approximately 60% cash and 40% stock.

On a pro forma basis, AV Homes stockholders are expected to own up to approximately 10% of the combined company, subject to conversion mechanics applicable to holders of AV Homes’ convertible notes.

AVHI closed at $16.50.


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GE creates new company to develop unmanned traffic management

GE creates  AiRXOS to develop unmanned traffic management 

GE introduces new company AiRXOS, Stockwinners
GE introduces new company AiRXOS

GE (GE) introduced AiRXOS a new company helping to accelerate the safe, efficient, scalable integration of air and ground space for manned and unmanned vehicles.

AiRXOS helps government agencies, regional aviation authorities and private sector operators manage and meet the increasing demand for sophisticated and safe Unmanned Aircraft Systems operations. AiRXOS is a wholly-owned subsidiary of GE.

The Department of Transportation recently announced the UAS IPP to help government agencies, municipalities, regional aviation authorities and private sector operators manage and meet the increasing demand for sophisticated and safe UAS operations.

Of the ten pilot programs, AiRXOS was selected as a partner for three: The City of San Diego, the City of Memphis, and the Choctaw Nation of Oklahoma. AiRXOS will work with these program partners in safely demonstrating capabilities such as operations over urban settings, night operations, beyond visual line of sight, as well as developing overall UTM systems.

Drive Ohio’s UAS Center announced an investment of $5.9M for UTM research that will include both air and ground vehicles and will complement Drive Ohio’s current efforts for autonomous and connected vehicle testing along the U.S. 33 Smart Mobility Corridor. AiRXOS has been selected as a partner, along with Gryphon Sensors, CAL Analytics, and Ohio State University’s College of Engineering to implement a UTM solution for the U.S. 33 Smart Mobility Corridor. AiRXOS has also formed a collaboration with NUAIR Alliance for an unmanned testing and rating initiative that will combine NUAIR’s new National Unmanned Systems Testing and Rating capability with AiRXOS’ Autonomous Service Platform.

While NUSTAR will objectively measure UAS performance and test systems against industry consensus standards, AiRXOS will automate the processes used by commercial operators, pilots, organizations, and drone manufacturers to engage in commercial flight operations.

To support this effort, AiRXOS plans to open an office in the Syracuse, New York Tech Garden offices. To keep pace with innovation, NASA’s Technical Capability Level testing and the expansion of the Low Altitude Authorization and Notification Capability service program continue to move the industry forward.

AiRXOS is a TCL partner and has recently applied for a LAANC application in support of bringing a broad range of UAS operations safely to scale.

GE closed at $13.64.


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